| CTRI Number |
CTRI/2021/09/036498 [Registered on: 14/09/2021] Trial Registered Prospectively |
| Last Modified On: |
24/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Study of effect ofalready approved drug] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Study Of Effect Of Dexmedetomidine Infusion On Extubation Time And Post Operative Sedation Scores In Patients Undergoing Long Duration Oncological Surgeries |
|
Scientific Title of Study
|
A comparative study of effect of dexmedetimidine infusion on extubation time and post operative sedation scores in patients undergoing long duration oncological surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Snehal Diwakar Thombre |
| Designation |
Post Graduate Student in Anaesthesiology |
| Affiliation |
IMS AND SUM HOAPITAL, Bhubaneshwar |
| Address |
IMS AND SUM HOAPITAL , BHUBANESHWAR
Khordha
ORISSA
751003
India |
| Phone |
9777309665 |
| Fax |
|
| Email |
snehalthombre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DAISY KARAN |
| Designation |
ASSOCIATE PROFFESOR |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
IMS AND SUM HOSPITAL
BHUBANESHWAR
Khordha
ORISSA
751003
India |
| Phone |
8895588133 |
| Fax |
|
| Email |
daisykaran84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal Diwakar Thombre |
| Designation |
Post Graduate Student in Anaesthesiology |
| Affiliation |
IMS NAD SUM HOSPITAL |
| Address |
IMS AND SUM HOAPITAL , BHUBANESHWAR
Khordha
ORISSA
751003
India |
| Phone |
9777309665 |
| Fax |
|
| Email |
snehalthombre@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IMS AND SUM HOAPITAL |
| Address |
IMS AND SUM HOSPITAL , KALINGA NAGAR , BHUBANESHWAR , ODHISA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SNEHAL DIWAKAR THOMBRE |
IMS AND SUM HOSPITAL |
IMS AND SUM HOSPITAL BHUBNESWAR
Khordha
ORISSA |
9777309665
snehalthombre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , IMS AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE INFUSION |
EFFECT OF DEXMEDETOMIDINE ON EXTUBATION TIME AND POSTOPERATIVE SEDATION TIME |
| Comparator Agent |
not applicable |
effect of same drug |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
WEIGHT BMI 20 TO 30 KILOGRAMS PER METERS SQUARE
ASA GRADE 1 AND 2
ONCOSURGERIES MORE THAN OR EQUALS TO 3 HOURS DURATION |
|
| ExclusionCriteria |
| Details |
REFUSAL BY PATIENT TO PARTICIPATE
ALLERGIC TO LOCAL ANAESTHETIC AGENT OR TO STUDY DRUG
ASA GRADE 3 AND 4
NEUROLOGICAL DISEASES
PATIENTS WITH METASTASIS AND SEPSIS
SURGERIES WHICH WILL PROLONG MORE THAN 4 HOURS
CASES WHERE TOP UP DOSE OF MUSCLE RELAXANT WILL BE GIVEN NEARBY END OF SURGERY |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO STUDY EFFECT OF DEXMEDETOMIDINE ON EXTUBATION TIME AND POST OPERATIVE RECOVERY SCORE |
AT EXTUBATION TIME AND IN POST OPERATIVE PERIOD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE HEMODYNAMIC RESPONSE AT EXTUBATION IN BOTH GROUPS AND ALSO DISCHARGE FROM POST ANAESTHESIA CARE UNIT |
AT EXTUBATION AND POSTANAESTHESIA CARE UNIT AT 5 MINUTES 10 MINUTES 15 MINUTES AND 30 MINUTES |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/10/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NOT PUBLISHED YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 02-02-2021 and end date provided 02-02-2022?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
TITLE A Comparative Study Of Effect Of Dexmedetomidine Infusion On Extubation Time And Post Operative Sedation Scores In Patients Undergoing Long Duration Oncological Surgeries. This study is a randomised, comparative, double-blind parallel-group study to record and compare the effect of dexmedetomidine infusion on extubation time and postoperative recovery score in long-duration oncological surgeries’ Primary objective: to study the effect of intraoperative dexmedetomidine infusion on extubation time and postoperative sedation score. Secondary objective: to study hemodynamic responses at extubation and time to discharge from the postanaesthesia care unit |